Complication of Surgical or Medical CareNCT04051749
Incidence, Predictors and Validation of Risk Scores to Predict Myocardial Infarction After Noncardiac Vascular Surgery
An observational study of Complication of Surgical or Medical Care, run by Centro Hospitalar De São João, E.P.E..
Trial summary
Evaluate the incidence and predictors of post-operative mortality after noncardiac Vascular Surgery and compare the performance of existing risk scores. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Complication of Surgical or Medical Care
- What is being tested?
- Noncardiac Vascular Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 306 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive patients submitted to elective arterial VS
Who may be able to join
- Elective arterial Vascular Surgery
- Patients > 18 years
Who cannot join
- Urgent/Emergent Surgery
- Patients < 18 years
About this study
Official title: Incidence, Predictors and Validation of Risk Scores to Predict Myocardial Infarction After Noncardiac Vascular Surgery, a Cohort Prospective Study
Evaluate the incidence and predictors of post-operative mortality after noncardiac Vascular Surgery and compare the performance of existing risk scores.
- Conditions
- Complication of Surgical or Medical Care
- Being tested
- Noncardiac Vascular Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noncardiac Vascular SurgeryProcedure or surgery
Noncardiac Vascular Surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients submitted to VS | Not described Receives: Procedure: Noncardiac Vascular Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Cardiac Events
Measured: 30-day
Secondary outcomes (1)
Mortality
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start1 Jan 2015
- Primary completion30 Apr 2015
- Study completion31 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complication of Surgical or Medical CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Reis, Centro Hospitalar De São João, E.P.E.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051749
- Sponsor's protocol ID
- CES 04-15
- Status last verified
- May 2020
- First submitted
- 8 Aug 2019
- Last updated
- 14 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reis P, Mourao J, Abelha F. Reply to the commentary on "Incidence, predictors and validation of risk scores to predict postoperative mortality after noncardiac vascular surgery, a prospective cohort study" [Int. J. Surg. 77 (2020) 181-2]. Int J Surg. 2020 Jul;79:47-49. doi: 10.1016/j.ijsu.2020.04.072. Epub 2020 May 11. No abstract available.
PubMed 32438070
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Predictors and Validation of Risk Scores to Predict Myocardial Infarction After Noncardiac Vascular Surgery, a Cohort Prospective Study
- ClinicalTrials.gov ID
- NCT04051749
- Acronym / sponsor ID
- CES 04-15
- Conditions
- Complication of Surgical or Medical Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.University, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Apr 2015 (actual)
- Study completion
- 31 Jul 2015 (actual)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the incidence and predictors of post-operative mortality after noncardiac Vascular Surgery and compare the performance of existing risk scores.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients submitted to VS | – | Procedure: Noncardiac Vascular Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients submitted to elective arterial VS
Key inclusion criteria (2 listed)
- Elective arterial Vascular Surgery
- Patients > 18 years
Key exclusion criteria (2 listed)
- Urgent/Emergent Surgery
- Patients < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noncardiac Vascular SurgeryNoncardiac Vascular Surgery | Procedure or surgery | Patients submitted to VS |
Primary outcome
Major Cardiac Events
Time frame: 30-day
1 secondary outcome
Mortality
Time frame: 30-day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Derived from this study: PubMed 32438070Reis P, Mourao J, Abelha F. Reply to the commentary on "Incidence, predictors and validation of risk scores to predict postoperative mortality after noncardiac vascular surgery, a prospective cohort study" [Int. J. Surg. 77 (2020) 181-2]. Int J Surg. 2020 Jul;79:47-49. doi: 10.1016/j.ijsu.2020.04.072. Epub 2020 May 11. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Surgical or Medical Care, run by Centro Hospitalar De São João, E.P.E..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Cardiac Events (time frame: 30-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04051749, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2020.